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Validation of a Delirium Monitor

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ClinicalTrials.gov Identifier: NCT02404181
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
University Medical Center Nijmegen
Isala
Charite University, Berlin, Germany
Information provided by (Responsible Party):
A.J.C. Slooter, UMC Utrecht

Brief Summary:

Delirium is a common disorder in hospitalized patients, nevertheless it is poorly recognized by physicians and nurses, even when screening instruments are used. Electroencephalography (EEG) appears to be a sensitive tool for the diagnosis of delirium. However, standard EEG recording with 25 electrodes is labor intensive. We have previously showed that a brief EEG registration with three electrodes and automatic processing can distinguish patients with delirium from patients without delirium very well. However, these findings need to be validated in an unselected population.

The primary objective of this validation study is to investigate the sensitivity, specificity, and predictive values of the EEG-based delirium monitor (including three electrodes and a reference electrode) compared to delirium quantification in frail elderly patients after surgery.

In an international multicenter study, 154 frail elderly patients will be included who will undergo elective surgery and are expected to remain admitted for at least two postoperative days. Patients are excluded if communication is not possible or admitted for neurological surgery.

A five minute EEG registration with the delirium monitor with four electrodes will be performed prior surgery and three consecutive days after surgery or until discharge. Within one hour of the EEG recording, the delirium assessment will be performed and recorded on video, which will be evaluated by delirium experts. The relative delta power (calculated from one minute of artifact-free EEG segment) will be compared with the conclusion of the delirium experts.


Condition or disease
Delirium

Study Type : Observational [Patient Registry]
Actual Enrollment : 159 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Days
Official Title: Validation of a Delirium Monitor in Postoperative Elderly Patients
Study Start Date : March 2014
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. Relative delta power (based on 1 min. artifact-free data) will be compared to the classification of the delirium expert in elderly postoperative patients resulting in the sensitivity, specificity and predictive values of the delirium monitor for each day [ Time Frame: 4 days ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The source population will consist of frail, elderly patients (≥60 years) who will undergo elective surgery in the University Medical Center Utrecht, Isala Clinics Zwolle, Radboud University Medical Center Nijmegen, or Charité Universitätsmedizin Berlin, and who will be expected to remain admitted for at least two postoperative days. These patients will be informed on this study before admission to the hospital.
Criteria

Inclusion Criteria:

  • 60 years and older
  • Frail
  • Undergoing elective surgery
  • Expected to remain admitted for at least 2 postoperative days

Exclusion Criteria:

  • No communication possible due to a language barrier or deafness
  • Admission for neurological surgery
  • Participation in this study during a previous hospital admission
  • Practical or logistical reasons hampering the use of the delirium monitor, such as technical failure of the monitor
  • Isolation because of known carrier ship of a resistant bacterium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404181


Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
University Medical Center Nijmegen
Isala
Charite University, Berlin, Germany

Responsible Party: A.J.C. Slooter, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02404181     History of Changes
Other Study ID Numbers: NL46622.041.13
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by A.J.C. Slooter, UMC Utrecht:
Validation Studies
EEG

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders